Stress Relief Properties of a Cosmetic Routine

NCT04127279 | Completed Phase 4

• 1 other identifier: 46700 18122017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters. The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, and Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments. Participants' informed consent signature for adhesion at the study was initially requested. With their acceptance, parameters were recorded anonimously, identified by their initials and an alphanumeric code. Data were transferred on Excel worksheets, utilized for descriptive analysis related at every variable. All statistical analyses were performed using SPSS 25 software package and statistical significance was set at p\<0.05.

Conditions

Stress Physiology; Stress, Psychological

Keywords

autonomic nervous system; HPA axis; anxiety; non verbal behavior

Outcome Measures

Primary Outcomes (9)

• Acute autonomic stress responsivity (heart rate, HR) to cream self-administration

  Mean HR, measured as bpm (beats per minute)

  ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)

• Acute autonomic stress responsivity (heart rate, HR) to cream self-administration

  Mean HR, measured as bpm (beats per minute)

  ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)

• Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration

  High frequency component power (HF) of the RR interval spectrum (n.u.)

  ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)

• Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration

  High frequency component power (HF) of the RR interval spectrum (n.u.)

  ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)

• Acute HPA axis stress responsivity to cream self-administration

  Determined by means of salivary cortisol levels (pg/ml)

  Samples obtained just before the self-administration of the enriched and placebo creams

• Acute HPA axis stress responsivity to cream self-administration

  Determined by means of salivary cortisol levels (pg/ml)

  Samples obtained after (20 min) the self-administration of the enriched and placebo creams

• Acute HPA axis stress responsivity to the psychosocial stress test

  Determined by means of salivary cortisol levels

  Samples obtained just before the psychosocial stress test

• Acute HPA axis stress responsivity to the psychosocial stress test

  Determined by means of salivary cortisol levels

  Samples obtained after (10 minutes) the psychosocial stress test

• Acute HPA axis stress responsivity to the psychosocial stress test

  Determined by means of salivary cortisol levels

  Samples obtained after (30 minutes) the psychosocial stress test

Secondary Outcomes (5)

• Perceived stress

  Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream

• Perceived stress

  After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream

• Profile of mood states

  Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream

• Profile of mood states

  After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream

• Behavioral coping style

  During the psychosocial stress test (PST, day 29)

Study Arms (2)

Enriched Cream

EXPERIMENTAL

The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil.

Biological: Cream

Placebo Cream

ACTIVE COMPARATOR

Cream devoid of essential oils, self-administered

Biological: Cream

Interventions

Cream BIOLOGICAL

The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil. The placebo cream is devoid of the essential oils

Enriched Cream; Placebo Cream

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female gender
• to 50 years old

You may not qualify if:

• current or past neurological, psychiatric, and cardiac disorders
• cognitive impairment
• substance or alcohol abuse or dependence
• recent (last 12 months) traumatic events such as a death in the family, serious accident, job firing or divorce
• caregiving (last 12 months) a family member with serious pathology or disability
• current psychotropic or contraceptive drug use

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University of Parma

Parma, 43124, Italy

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Andrea Sgoifo, PhD

  University of Parma

  PRINCIPAL INVESTIGATOR

• Luca Carnevali, PhD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 15, 2019
• Study Start: January 15, 2018
• Primary Completion: September 28, 2018
• Study Completion: December 14, 2018
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

IT (1)